Sr Mgr Information Systems

Career Category Information Systems Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Senior Manager Information Systems What you will do Let s do this Let s change the world The role is responsible for leading and charting the course for the Clinical Data Management and Interactive Response Technologies CDMIRT technology product team that builds and transforms technology capabilities that positively impacts business outcomes This individual will be responsible for planning design configuration deployment and support of Veeva Clinical Data Management System CDMS and Clinical Database CDB systems The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry Additionally collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner coupled with leadership and transformation experience This role demands the ability to drive and deliver against key organizational strategic initiatives foster a collaborative environment and deliver high-quality results in a matrixed organizational structure Roles Responsibilities Conducting detailed analysis of clinical trial processes to identify and document functional requirements for Veeva CDMS including data capture data validation reporting and workflow management Collaborating with technical teams to design system configurations data mappings and integrations between Veeva platforms and other clinical systems Ensuring data integrity by defining data quality standards monitoring data quality issues and working with data stewards to address discrepancies Supporting the validation processes defined by Amgen for the Veeva CDMS and CBD systems ensuring compliance with regulatory standards e g FDA GxP throughout the implementation and ongoing usage Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage large diverse teams within a matrixed organization Collaborate with geographically dispersed teams including those in the US and other international locations Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce Develop a culture of collaboration innovation and continuous improvement Develop talent motivate the team delegate effectively champion diversity within the team and act as a role model of servant leadership Responsible for leading growing and developing the Amgen Technology team in India ensuring global ways of working are imbedded in the local organization Understand the decision-making process workflows and business and information needs of business partners and collaborators Contribute and define business outcomes requirements technology solutions and services Improve activities being measured by crafting monitoring and optimizing relevant feedback loops through test learn activities Work with Product Owners Service Owners and or delivery teams to ensure that delivery matches commitments acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings working with other parts of the organization and functional groups to ensure successful delivery Ensure ongoing alignment with strategy compliance and regulatory requirements for technology investments and services Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality compliance requirements such as GXP and Privacy What we expect of you We are all different yet we all use our unique contributions to serve patients Basic Qualifications Doctorate Degree and 2 years of experience in Business Engineering IT or related field OR Master s degree with 8 - 10 years of experience in Business Engineering IT or related field OR Bachelor s degree with 10 - 14 years of experience in Business Engineering IT or related field OR Diploma with 14 - 18 years of experience in Business Engineering IT or related field Solid understanding of clinical trial processes including study design data collection data management and regulatory requirements Expertise in Veeva CDMS and CDB functionalities including data entry data review reporting and workflow management Experience with business analysis methodologies including requirements gathering documentation and process mapping Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation Exceptional collaboration communication and interpersonal skills to effectively manage partner relationships and build new partnerships Experience in applying technology best practice methodologies Scaled Agile SAFe ITIL etc Preferred Qualifications Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle Experience using and adoption of Scaled Agile Framework SAFe Strong analytic critical-thinking and decision-making abilities Ability to work effectively in a fast-paced dynamic environment Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Scaled Agile Framework SAFe for Teams required Soft Skills Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global virtual teams What you can expect of us As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation